BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI TRAY TRIAL HANDLE

    MDR report key: 1162853 · Received September 9, 2008

    Report

    Report Number
    1226188-2008-00028
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 8, 2008
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PIN USED TO PULL THE LOCKING PIN BACK WAS MISSING. THE PIN IS PRESSED INTO POSITION DURING MANUFACTURE OF THE INSTRUMENT. A DESIGN CHANGE WILL BE IMPLEMENTED TO PLUG THE TWO POSSIBLE PATHS FOR THE PIN TO BACK OUT. INSTRUMENT IS CLASS 1 EXEMPT.

    Description of Event or Problem · 1

    TRAY TRIAL HANDLE/INSTRUMENT BROKE DURING SURGERY, THERE WAS ANOTHER INSTRUMENT AVAILABLE, BUT CAUSED A 20 - 30 MINUTE DELAY IN SURGERY. NO PATIENT PROBLEM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI TRAY TRIAL HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH OMNI LIFE SCIENCE, INC. 700225 C0608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention